A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2
- Conditions
- Carcinoma, Non-Small-Cell LungOvarian NeoplasmsEndometrial NeoplasmsHead and Neck Neoplasms
- Interventions
- Registration Number
- NCT06003231
- Lead Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Brief Summary
This clinical trial is studying advanced or metastatic solid tumors. Once a solid tumor has grown very large in one spot or has spread to other places in the body, it is called advanced or metastatic cancer. Participants in this study must have head and neck cancer, non-small cell lung cancer, endometrial cancer, or ovarian cancer. In the first part of the study, participants must have tumors that have a marker called HER2.
This clinical trial uses an experimental drug called disitamab vedotin (DV). DV is a type of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. In this study, all participants will get DV once every 2 weeks.
This study is being done to see if DV works to treat different types of solid tumors that express HER2. It will also test how safe the drug is for participants. This trial will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 119
-
Cohort 1: Head and neck cancer (HNC)
-
Must have pathologically-documented carcinoma of the head and neck with primary tumor site arising from the oral cavity, salivary gland, oropharynx, hypopharynx, and larynx; tumors arising from the nasopharynx are excluded.
-
Unresectable locally recurrent or metastatic stage disease
-
Prior therapies:
- Participants must have disease progression after treatment with a platinum-based therapy
-
-
Cohort 2: Non-small cell lung cancer (NSCLC)
-
Pathologically documented NSCLC
-
Unresectable locally-advanced or metastatic stage disease
-
Prior therapies
- Must have progressed during or after a platinum-based therapy for LA/metastatic disease or, within 6 months of platinum-based adjuvant, neoadjuvant, or concomitant chemoradiotherapy for early or locally-advanced stage disease
- Must have received prior anti-PD(L)1 therapy, unless contraindicated
- Participants with known AGAs must have received appropriate targeted therapy, where available.
- No more than 2 prior lines of cytotoxic chemotherapy for advanced disease
-
-
Cohort 3: Ovarian Cancer
-
Pathologically documented epithelial cancers of ovarian, fallopian tube, or peritoneal origin
-
Unresectable locally-advanced or metastatic stage disease
-
Prior therapies
- Must have platinum resistant disease (6 months or less between the completion of platinum-based treatment and identification of recurrence)
- Must not have received more than 4 lines of prior cytotoxic chemotherapies for advanced disease
- Participants with known BRCA mutations are permitted, but participants must have received targeted therapy with a PARP inhibitor
- May have received prior anti-PD(L)1 therapy
-
-
Cohort 4: Endometrial Cancer
-
Must have pathologically documented adenocarcinoma of the endometrium
-
Must have unresectable locally-advanced or metastatic stage disease.
-
Prior therapies
- Must have relapsed/progressed after at least one prior platinum-based chemotherapy for recurrent, metastatic or primary unresectable disease
- Must not have received more than 3 lines of prior cytotoxic chemotherapies for advanced disease
- May have received prior anti-PD(L)1 therapy
-
-
HER2 expression of 1+, 2+, or 3+, as determined by local IHC testing on a fresh or archival tumor tissue. Note: Participants with HER2 mutations are eligible.
-
Measurable disease per RECIST v1.1 criteria as assessed by the investigator
-
Able to provide formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides)
-
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Prior treatment with an MMAE-containing agent.
- Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin.
- History of another invasive malignancy within 2 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
- Active untreated CNS or leptomeningeal metastasis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Head and neck cancer disitamab vedotin Disitamab vedotin monotherapy Non-small cell lung cancer disitamab vedotin Disitamab vedotin monotherapy Ovarian cancer disitamab vedotin Disitamab vedotin monotherapy Endometrial cancer disitamab vedotin Disitamab vedotin monotherapy
- Primary Outcome Measures
Name Time Method Confirmed Objective Response Rate (ORR) per Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment Approximately 3 years The proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator
- Secondary Outcome Measures
Name Time Method Number of participants with laboratories abnormalities Through 30-37 days after the last dose of DV; approximately 5 years Overall Survival (OS) Approximately 5 years The time from the start of study treatment to the date of death due to any cause
Number of participants with adverse events (AEs) Through 30-37 days after the last dose of DV; approximately 5 years Any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
PK parameter - Maximum concentration (Cmax) Through 30-37 days after the last dose of DV; approximately 5 years Analyzed through end of treatment.
Incidence of antidrug antibodies (ADAs) Through 30-37 days after the last dose of DV; approximately 5 years Number of participants with dose alterations due to AEs Approximately 5 years Confirmed Disease Control Rate (DCR) per RECIST v1.1 by investigator assessment Approximately 5 years The proportion of participants with stable disease (SD) or confirmed CR or PR according to RECIST v1.1
PK parameter - Trough concentration (Ctrough) Through 30-37 days after the last dose of DV; approximately 5 years Analyzed through end of treatment.
Duration of Response (DOR) per RECIST v1.1 by investigator assessment Approximately 5 years The time from start of the first documentation of objective tumor response of CR or PR (that is subsequently confirmed) to the first documentation of progressive disease (PD) per RECIST v1.1, or to death due to any cause
Pharmacokinetic (PK) parameter - Area under the concentration-time curve to the time of the last quantifiable concentration (AUClast) Approximately 1 month Analyzed through cycle 2.
Progression free survival (PFS) per RECIST v1.1 by investigator assessment Approximately 5 years PFS is defined as the time from the start of study treatment to the first documentation of PD per RECIST v1.1 or death due to any cause, whichever occurs first
Trial Locations
- Locations (112)
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
🇺🇸Mineola, New York, United States
Charite Campus Benjamin Franklin
🇩🇪Berlin, Germany
Charite Berlin-Campus Virchow
🇩🇪Berlin, Germany
Renovatio Clinical
🇺🇸The Woodlands, Texas, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Fred Hutchinson Cancer Research Center | Seattle, WA
🇺🇸Seattle, Washington, United States
Blacktown Hospital
🇦🇺Blacktown, New South Wales, Australia
Macquarie University Hospital
🇦🇺Macquarie, New South Wales, Australia
Chris O'Brien Lifehouse
🇦🇺Camperdown, Australia
Chungbuk National University Hospital
🇰🇷Cheongju-si, Chungcheongbuk-do, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Spain
Clinica Universidad de Navarra
🇪🇸Pamplona, Spain
The Royal Marsden NHS Foundation Trust (RM)
🇬🇧London, United Kingdom
University College London Hospitals NHS Foundation Trust
🇬🇧London, United Kingdom
Renovatio Clinical.
🇺🇸El Paso, Texas, United States
Johanniter Krankenhaus Bonn
🇩🇪Bonn, Germany
Kronen - Apotheke Marxen
🇩🇪Wesseling, Germany
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
🇺🇸Scottsdale, Arizona, United States
Valkyrie Clinical Trials
🇺🇸Los Angeles, California, United States
Fondazione IRCCS San Gerardo dei Tintori.
🇮🇹Monza, Monza AND Brianza, Italy
UOC Radiologia BR - AOUI Verona
🇮🇹Verona, Italy
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
Azienda Ospedaliera Universitaria Integrata di Verona
🇮🇹Verona, Italy
Providence Medical Foundation
🇺🇸Santa Rosa, California, United States
Duke University Medical Center, Investigational Chemotherapy Services
🇺🇸Durham, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Gabrail Cancer Center Research
🇺🇸Canton, Ohio, United States
Providence Cancer Institute Franz Clinic
🇺🇸Portland, Oregon, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Providence St. Vincent Medical Center- Investigational Drug Services
🇺🇸Portland, Oregon, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
University of Texas Southwestern Medical Center - Simmons Cancer Center
🇺🇸Dallas, Texas, United States
University of Texas Southwestern Medical Center-Zale Lipshy University Hospital
🇺🇸Dallas, Texas, United States
University Of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Renovatio Clinical- Dr. Haroutioun Shahinian, MD, PA
🇺🇸El Paso, Texas, United States
Colorado West Healthcare System, dba Community Hospital
🇺🇸Grand Junction, Colorado, United States
Smilow Cancer Hospital at Yale - New Haven
🇺🇸New Haven, Connecticut, United States
Yale-New Haven Hospital-Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Smilow Cancer Hospital Phase 1 Unit
🇺🇸New Haven, Connecticut, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Smilow Cancer Hospital Care Center at Trumbull
🇺🇸Trumbull, Connecticut, United States
Centro Ricerche Cliniche Verona s.r.l. presso Ospedale G.B. Rossi Borgo Roma
🇮🇹Verona, Italy
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
🇺🇸Coral Gables, Florida, United States
University of Miami Hospital and Clinics Deerfield Beach
🇺🇸Deerfield Beach, Florida, United States
Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
University of Miami Hospital And Clinics
🇺🇸Miami, Florida, United States
Sylvester Comprehensive Cancer Center - Kendall
🇺🇸Miami, Florida, United States
University of Texas Southwestern Simmons Cancer Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Texas Southwestern Simmons Cancer Center - Richardson/Plano
🇺🇸Richardson, Texas, United States
Renovatio Clinical - Genesis Medical Group
🇺🇸Tomball, Texas, United States
Pacific Gynecology Specialists
🇺🇸Seattle, Washington, United States
Swedish First Hill IDS Pharmacy
🇺🇸Seattle, Washington, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Sylvester Comprehensive Cancer Center Plantation
🇺🇸Plantation, Florida, United States
Georgia Cancer Center at Augusta University
🇺🇸Augusta, Georgia, United States
Wellstar MCG Health Clinical Research Pharmacy
🇺🇸Augusta, Georgia, United States
IDS Pharmacy Room NGW516/506
🇺🇸Baltimore, Maryland, United States
University of Maryland Greenebaum Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States
University of Maryland Medical System
🇺🇸Baltimore, Maryland, United States
Dana-Farber Cancer Institute (DFCI)
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital (BWH)
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute - Chestnut Hill
🇺🇸Newton, Massachusetts, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Karmanos Cancer Institute Weisberg Cancer Treatment Center
🇺🇸Farmington Hills, Michigan, United States
Minnesota Oncology Hematology, P.A.
🇺🇸Minneapolis, Minnesota, United States
Allina Health Cancer institute
🇺🇸Coon Rapids, Minnesota, United States
M Health Fairview Cancer Clinic-Edina
🇺🇸Edina, Minnesota, United States
M Health Fairview St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
Allina Health Cancer Institute (Virginia Piper Cancer Institute)
🇺🇸Minneapolis, Minnesota, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
North Memorial Health Cancer Center
🇺🇸Robbinsdale, Minnesota, United States
Park Nicollet Frauenshuh Cancer Center
🇺🇸Saint Louis Park, Minnesota, United States
CHA University CHA Bundang Medical Center
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Grupo Hospitalario Quiron
🇪🇸Barcelona, Spain
Hospital Universitari Vall D Hebron
🇪🇸Barcelona, Spain
Regulatory location : MMCORC
🇺🇸Saint Louis Park, Minnesota, United States
Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
Allina Health Cancer Institute-United(VPCI)
🇺🇸Saint Paul, Minnesota, United States
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Provincial
🇪🇸Cordoba, Spain
Clinica Universidad de Navarra Madrid
🇪🇸Madrid, Spain
Macquarie University Clinical Trials Unit.
🇦🇺Macquarie, New South Wales, Australia
Macquarie University Clinic
🇦🇺Macquarie, New South Wales, Australia
Minnesota Oncology Hematology, P.A. Cornerstone Medical Specialty Center
🇺🇸Woodbury, Minnesota, United States
Macquarie University Hospital Pharmacy
🇦🇺Macquarie, New South Wales, Australia
Baxter Healthcare
🇦🇺Old Toongabbie, New South Wales, Australia
Peninsula & South Eastern Hematology and Oncology Group (PASO)
🇦🇺Frankston, Victoria, Australia
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana
🇺🇸Billings, Montana, United States
Intermountain Health St. Vincent Regional Hospital
🇺🇸Billings, Montana, United States
Intermountain Health - West End Clinic Gynecologic Oncology
🇺🇸Billings, Montana, United States
Optimum Clinical Research Group, LLC
🇺🇸Albuquerque, New Mexico, United States
Southwest Women's Oncology Inc
🇺🇸Albuquerque, New Mexico, United States
NYU Langone Hospital - Long Island
🇺🇸Mineola, New York, United States
NYU Langone Hospital-Long Island
🇺🇸Mineola, New York, United States
Johanniter GmbH, Johanniter Krankenhaus Bonn
🇩🇪Bonn, NRW, Germany
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
CHU de Québec-Université Laval
🇨🇦Quebec, Canada
The Blavatnik Family-Chelsea Medical Center at Mount Sinai
🇺🇸New York, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
🇺🇸New York, New York, United States
Laura & Issac Perlmutter Cancer Center-NYU Ambulatory Care Center(ACC)
🇺🇸New York, New York, United States
New York University (NYU) Cancer Institute
🇺🇸New York, New York, United States
NYU Langone Hospitals
🇺🇸New York, New York, United States
NYU Langone Medical Center (Tisch Hospital)
🇺🇸New York, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Ruttenberg Treatment Center
🇺🇸New York, New York, United States
The Mount Sinai Hospital
🇺🇸New York, New York, United States